摘要
到目前为止,两种粒细胞集落刺激因子(G-CSF)已被批准用于自体外周血造血干细胞(PBSC)大剂量化疗后的动员和移植后血液学恢复:filgrastim(创始者和生物仿制药)和lenograstim。按照已批准生物仿制药的基础上相媲美的疗效和安全性临床研究,它已被用于预防化疗引起的发热性中性粒细胞减少,但没有具体的预注册研究已发表在移植设置。因此,仍然有关于生物仿制药的粒细胞集落刺激因子的患者在此设置的作用普遍怀疑。本文对生化、临床前和临床数据表明,生物仿制药的Filgrastim显著相似性与发起人粒细胞集落刺激因子和移植后血液学恢复在自体外周血干细胞和移植后血液学恢复。
关键词: 自体干细胞移植,生物仿制filgrastim,血液学恢复,lenograstim,filgrastim创立者,外周血造血干细胞动员。
Current Medicinal Chemistry
Title:Biosimilar Filgrastim in Autologous Peripheral Blood Hematopoietic Stem Cell Mobilization and Post-Transplant Hematologic Recovery
Volume: 23 Issue: 21
Author(s): Francesco Marchesi, Andrea Mengarelli
Affiliation:
关键词: 自体干细胞移植,生物仿制filgrastim,血液学恢复,lenograstim,filgrastim创立者,外周血造血干细胞动员。
摘要: To date, two kinds of Granulocyte Colony-Stimulating Factors (G-CSF) have been approved for autologous peripheral blood hematopoietic stem cell (PBSCs) mobilization and posttransplant hematologic recovery after high-dose chemotherapy: filgrastim (originator and biosimilar) and lenograstim. Biosimilar filgrastim has been approved on the basis of comparable efficacy and safety in clinical studies where it has been used as chemotherapy-induced febrile neutropenia prophylaxis, but no specific pre-registration studies have been published in the transplant setting. Hence, there is still general skepticism about the role of biosimilar G-CSFs in this setting of patients. This review of biochemical, pre-clinical and clinical data suggests significant comparability of biosimilar filgrastim with both originator filgrastim and lenograstim in autologous PBSCs mobilization and post-autograft hematologic recovery.
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Cite this article as:
Francesco Marchesi, Andrea Mengarelli , Biosimilar Filgrastim in Autologous Peripheral Blood Hematopoietic Stem Cell Mobilization and Post-Transplant Hematologic Recovery, Current Medicinal Chemistry 2016; 23 (21) . https://dx.doi.org/10.2174/0929867323666160517115907
DOI https://dx.doi.org/10.2174/0929867323666160517115907 |
Print ISSN 0929-8673 |
Publisher Name Bentham Science Publisher |
Online ISSN 1875-533X |
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